Brain NeoplasmsPhase 1NCT00393965
Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
A Phase 1 study testing MPC-6827 in people with Brain Neoplasms, run by Myrexis Inc. at 1 site in United States.
Trial summary
Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- MPC-6827
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory Brain Metastases
- At least 1 measurable intracranial lesion as defined by RECIST
- ECOG less than or equal to 1
- Adequate hematology/organ function
- No baseline peripheral or central neuropathy above grade 1
Who cannot join
- Hypersensitivity to Cremophor EL
- Pregnant or Lactating
- Spinal Cord Compression
- Pre-existing dementia/cognitive disfunction
- Require Neupogen or Neulasta to Maintain Neutrophil Count
- Have Primary Brain Cancer
- Have History of Ischemic Heart Disease
- Have Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases
Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.
- Conditions
- Brain Neoplasms
- Being tested
- MPC-6827
- Keywords
- Metastases, Refractory, Brain
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPC-6827Drug
2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: 1 year
Pharmacokinetics
Measured: 1 year
Secondary outcomes (1)
Antitumor Activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startDec 2005
- Primary completionAug 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margaret Yu, MD, Study director, Myrexis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393965
- Sponsor's protocol ID
- MPC-6827-04-002
- Status last verified
- Feb 2008
- First submitted
- 30 Oct 2006
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases
- ClinicalTrials.gov ID
- NCT00393965
- Acronym / sponsor ID
- MPC-6827-04-002
- Conditions
- Brain Neoplasms
- Keywords
- Metastases, Refractory, Brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 31 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refractory Brain Metastases
- At least 1 measurable intracranial lesion as defined by RECIST
- ECOG less than or equal to 1
- Adequate hematology/organ function
- No baseline peripheral or central neuropathy above grade 1
Key exclusion criteria (8 listed)
- Hypersensitivity to Cremophor EL
- Pregnant or Lactating
- Spinal Cord Compression
- Pre-existing dementia/cognitive disfunction
- Require Neupogen or Neulasta to Maintain Neutrophil Count
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPC-68272-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle. | Drug | – |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 year
Pharmacokinetics
Time frame: 1 year
1 secondary outcome
Antitumor Activity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Yu, MD study director
Myrexis Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MPC-6827 in people with Brain Neoplasms, run by Myrexis Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2008.